Pharmacovigilance Manager

Вакансия № 5038777 от компании VALEANT на Электронной Службе Занятости Населения Москвы.

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☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 5038777 добавлено в базу данных: Среда, 12 февраля 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Статистика предложения работы № 5038777:

Прочитано соискателями - 225 раз(а);
Отправлено откликов - 1 раз(а);

☑ Репутация компании "VALEANT":

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☑ Подробности о вакантном месте:

To coordinate day-to-day management of the pharmacovigilance local system in Eurasian Markets Region (EMR) and ensure local compliance with applicable Regulations and Corporate policies (local and global)
To act as Deputy National Responsible Person in terms of EU Directive 2010/84/EС and local legislation
To facilitate Pharmacovigilance training at a local and regional level (as applicable)
To support Safety Data Exchange Agreement (SDEA) preparation and updates

Responsibilities:

Responsible for local Pharmacovigilance System (EMR)
To ensure all local affiliate responsibilities are fulfilled as documented globally and in the PSMF
Intake, if applicable translate, and forward Adverse Events regarding pharmaceuticals and medical devices for processing within the Global Pharmacovigilance and Risk Management (GPRM) team, ensuring all cases are processed in a timely manner
Perform/manage reconciliation of Adverse Events for EMR
Prepare and manage local SOPs and written procedures according to local legislations and in line with Pharmacovigilance global SOPs
Ensure that local pharmacovigilance system is managed with local SOPs
Preparation and updating of SDEAs
Acting as the local Pharmacovigilance (PV) contact person for local health authorities and for the EU QPPV, as required
Support compilation of aggregate reports by providing requested EMR specific data
Participate in global PV training activities
Manage PV training for local affiliate employees incl. sales representatives as applicable
Support labeling update activities
Support Direct Healthcare Professional Communication and other risk minimisation measures, if applicable
Perform/organize local literature search (journals not listed in EMBASE); maintain, check and update list, documentation of local literature search
Keep senior managers updated of changes in local responsible persons
Keep local PV SOP updated on a regular basis
Act as local contact point for audit and inspections and related processes, including the preparation and maintenance of Inspection Binder
Support review of local agreements and compliance
To ensure appropriate archiving of relevant documentation and correspondence
To represent GPRM and the company in an ethical and positive manner
Work independently and responsibly in occasional work from home environment

Qualifications:

Degree in Medical Science strongly preferred or Pharmacist, Life Sciences degree
Knowledge of EMR laws and guidelines related to medicinal products and medical devices
Good spoken and written English knowledge, including medical terminology
Basic computer literacy, including Excel and PowerPoint
Analytical thinking and problem-solving skills
Excellent interpersonal and presentation skills
Strong patient orientation
Minimum 2-4 years of working experience in pharmaceutical industry
Minimum 2-4 years of experience performing the functions of pharmacovigilance or materiovigilance, including review and reporting of adverse events, communication with Health Authorities/notified bodies